Renal Cancer
Conditions
Interventions
None listed
Sponsors
University of Yamanashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above with metastatic renal cell carcinoma 2. Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST 3. Presence of two or more clinically measurable lesions (assessed by CT, MRI, physical examination, or visual inspection) Note: Osteosclerotic lesions without measurable soft-tissue components are excluded 4. Planned to undergo IGU to the target lesion 5. Provided written informed consent after receiving sufficient explanation of this study Note: Proxy signature is permitted if the patient is physically unable to sign
Exclusion criteria
Exclusion criteria: 1. Patients with active double cancers (synchronous double cancers or metachronous double cancers with a disease-free interval within 2 years). However, carcinoma in situ or intramucosal carcinoma considered cured by treatment, and the following tumors even if within 2 years of disease-free interval are not excluded: gastric cancer stage 0-II (UICC), prostate cancer stage I-III, colorectal cancer stage 0-II, esophageal cancer stage 0-I, breast cancer stage 0-II, endometrial cancer stage I-II, cervical cancer stage 0-II, and thyroid cancer stage I-III. In addition, any cancer with a disease-free interval greater than 2 years is not excluded regardless of stage. 2. Patients with serious comorbidities, such as: - severe cardiac disease - uncontrolled diabetes mellitus despite continuous insulin therapy - myocardial infarction within 6 months - uncontrolled hypertension - active infections (bacterial, viral, or fungal) - diarrhea (watery stool), paralytic ileus, or bowel obstruction - autoimmune disease - any other severe comorbid condition 3. Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT 4. Patients with acute-phase pneumonia 5. Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abscopal response rate (ARR) at 1 year after IGU | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1. Tumor shrinkage rate of irradiated and non-irradiated lesions at each assessment time point during follow-up 2. 1-year overall survival (OS) 3. 1-year disease-specific survival (DSS) 4. 1-year progression-free survival (PFS) Exploratory Endpoint 1. To evaluate the association between treatment response and changes in circulating cytokine levels before and after IGU | — |
Countries
Japan
Contacts
Public ContactZhe Chen
Faculty of Medicine, University of Yamanashi Department of Therapeutic Radiology
Outcome results
None listed